US3508538A - Method and apparatus for positioning the ventricular lead of a cardiac pacer - Google Patents

Method and apparatus for positioning the ventricular lead of a cardiac pacer Download PDF

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Publication number
US3508538A
US3508538A US685062A US3508538DA US3508538A US 3508538 A US3508538 A US 3508538A US 685062 A US685062 A US 685062A US 3508538D A US3508538D A US 3508538DA US 3508538 A US3508538 A US 3508538A
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Prior art keywords
pacer
electrode
cardiac
circuit
threshold
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John Walter Keller Jr
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TPL-CORDIS Inc A DE CORP
Telectronics Inc
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Cordis Corp
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Assigned to SOUTHEAST BANK, N.A., MIDLAND BANK PLC (SINGAPORE BRANCH) CREDIT LYONNAIS (CAYMAN ISLANDS BRANCH) reassignment SOUTHEAST BANK, N.A., MIDLAND BANK PLC (SINGAPORE BRANCH) CREDIT LYONNAIS (CAYMAN ISLANDS BRANCH) SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CORDIS HEADS, INC.
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Assigned to CORDIS LEADS, INC., 10555 W. FLAGLER STR., MIAMI, FL 33174 reassignment CORDIS LEADS, INC., 10555 W. FLAGLER STR., MIAMI, FL 33174 RELEASED BY SECURED PARTY (SEE DOCUMENT FOR DETAILS). RECORDED AT REEL 4747, FRAMES 503-504, OCT. 02, 1987 Assignors: SOUTHEAST BANK, N.A., MIDLAND BANK PLC AND CREDIT LYONNAIS
Assigned to TELECTRONICS, INC., A DE CORP. reassignment TELECTRONICS, INC., A DE CORP. NUNC PRO TUNC ASSIGNMENT (SEE DOCUMENT FOR DETAILS). Assignors: TPL-CORDIS, INC.
Assigned to TPL-CORDIS, INC., A DE CORP. reassignment TPL-CORDIS, INC., A DE CORP. NUNC PRO TUNC ASSIGNMENT (SEE DOCUMENT FOR DETAILS). Assignors: CORDIS LEADS, INC.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting

Definitions

  • the pulse level of the pacer is reduced by the attenuator by a factor at least as great as the normal post-operative rise in the threshold of ventricular response.
  • the electrode is then repositioned until the attenuated stimulus proves adequate.
  • the attenuator is removed and the pacer is connected directly to the electrode for implantation.
  • the electrodes are placed in their final position without a true knowledge of, their proximity to endocardial depolarizable tissue. Consequently, the initial, or acute threshold of stimulation (during implant) can vary widely; observations having been made as low as 0.3 ma. and higher than ma. If the ventricular electrode is left in a position where the acute threshold is as great as 3 or 4 ma., the postoperative or chronic threshold might very well be in excess of the pacer output. Thus, to effect successful pervenous electrode implantation, there must be provision for a measure of the acute threshold value. And the electrode should be so located that this threshold is a factor of at least 5 below the output capability of the stimulator.
  • Patented Apr. 28, 1970 Surgical and cardiac-catheterization teams generally prefer to minimize the use of complex measuring equipment in the operating area. Further, such equipment is used so seldom in hospitals that its calibration is not generally accurate. And batteries used in the equipment often require replacement just at the time when the equipment is needed. Thus, the requirement that the implanting physician measure the acute thresholds of implanted electrodes imposes considerable burdens.
  • the ventricular electrode is first implanted in the heart in a tentative position by conventional techniques, ordinarily by pervenous insertion into the endocardium. I then temporarily connect signalattenuating means of a fixed resistance value between the electrode and a cardiac pacer of any conventional type which may be prescribed.
  • the attenuating means is selected with reference to the open-circuit voltage of the particular pacer, to reduce the current of the pulses supplied to the ventricle by a factor which exceeds the increase in the threshold of response which is normally encountered post-operatively because of the growth of scar tissue.
  • the attenuated pulse level is preferably reduced by a factor of at least five from the output capability of the pacer.
  • a plurality of attenuators having resistance values graduated around a range of interest can also be substituted successively in the pacer-electrode circuit, for a more accurate determination of the true acute current threshold.
  • the attenuator is removed from the circuit, and the ventricular electrode lead is connected directly into the pacer in the usual fashion.
  • the pacer may then be permanently implanted in a subcutaneous pocket, or externally mounted, as appropriate to its type.
  • the attenuating circuit means may assume the form of a plug, containing the resistance or impedance devices making up the circuit, and having a male contact receivable in the female socket with which the pacer is ordinarily provided for receiving the ventricular lead.
  • the plug may also have a simple pressure clip for temporary attachment to the ventricular lead.
  • FIG. 1 is a schematic view of apparatus arranged according to the invention for testing the acute threshold of an implanted ventricular electrode
  • FIG. 2 shows the arrangement of the cardiac pacer and electrode after the completion of the threshold testing procedure, and ready for implantation of the pacer
  • FIG. 3 is a sectional view of attenuating means used in the procedure illustrated in FIG. 1.
  • a cardiac pacer is generally illustrated at 10, and this may be any of a variety of types as prescribed to suit the patients particular requirements.
  • the pacer comprises a self-contained oscillator circuit and source of potential, for producing electrical pulses for the stimulation of the ventricles.
  • the pulses may, for example, be generated at a fixed rate, or in delayed synchronism with signals produced by contraction of the atrium and received through a further lead (not shown) implanted in the heart.
  • Various types of conventional pacer circuits are described, in Cardiac Pacemakers, by Siddons and Sowton, Charles C. Thomas, Springfield, Ill., 1967. Pacer circuits are well known to those skilled in the art, and no further description thereof is believed necessary to an understanding of the present invention.
  • the pacer extends into a plug 12, which is provided with sockets for electrical connection to one or more ventricular leads 24, and to an atrial lead where the latter is employed.
  • the initial step in implanting the pacer system is to extend the lead 24, having a ventricular electrode 26 extending from its end, through an incision 28 into the venous system, and thence into the endocardium of the patients heart.
  • the attenuator 16 has a shell 17 of insulating material, and a male contact 18 protrudes from one end thereof for insertion into a ventricle lead socket (not shown) in the plug 12 of the pacer.
  • a set screw 14 is provided to grip the contact securely.
  • a conductive spring clamp 20 is secured in the shell 17 for gripping the lead terminal 22.
  • a resistive circuit is formed by a resistor connected between the contact 18 and the clamp 20.
  • the pacer extends into a plug 12, which is provided either constant current or constant voltage.
  • a suitable resistance value for the attenuator 16 is found simply by dividing the open circuit voltage of the pacer by a value of stimulating current which is a fraction of its normal maximum output capability, in the range of approximately A; to The post-operative threshold current for ventricular response, or chronic threshold rises by a factor of about 3 to 5 times the initial threshold on implantation. Therefore, the resistance should reduce the pacer output current by a factor which is at least equal to, and preferably greater than, the ratio of the normal output current to the chronic current threshold.
  • the selected factor is preferably at least five. As an example, assume an open-circuit pacer output voltage of 6 volts and a normal output current of 5 ma. Reduction of the output by a factor of five, that is to 1 ma., requires a resistance of approximately 6000 ohms, ignoring the impedance of the lead and electrode.
  • the contractions of the ventricles are observed by electrocardiogram with the apparatus of FIG. 1 in place. If the stimulation is effective to produce an adequate cardiac response, it can be assumed that the post-operative chronic threshold will be less than the output capability of the pacer, provided only that the electrode 26 remains in its implanted position. In the event, however, that inadequate cardiac stimulation is observed, the surgeon merely repositions the electrode to correct the deficiency. As soon as correct placement has been verified, the attenuator 16 is removed from the circuit, and the lead 24 is plugged directly into the pacer plug'12 as shown in FIG. 2. The terminal 22 extends into a neck or stylet 23, for secure engagement in the plug by means of the set screw 14. Normal procedures are then followed to implant the pacer in a subcutaneous pocket; or it may be mounted externally if appropriate.
  • a series of the attenuators 16, having different resistance values for reducing the stimulating current by a range of factors, can be successively connected in the circuit of FIG. 1 to provide the physician with a convenient and inexpensive means of determining, as accurately as may be desired, the true current threshold of the implanted electrode.
  • the method of implanting a ventricular electrode in effective contact with cardiac tissue of a patient, for connection to an electrical cardiac pacer circuit to supply ventricular stimuation pulses which comprises the steps of:
  • a threshold tester for use in cardiac pacer apparatus including circuit means for delivering electrical signal pulses of a predetermined level at intervals and means including a lead for conducting said pulses to the heart of the patient to act as ventricular stimuli, said circuit means having a socket and said lead having a contact for electrical connection there-between;
  • said threshold tester comprising an insulating shell, a
  • tester contact for electrical connection in said circuit means socket, clip means for electrical connection with said lead contact, and resistance means connected between said tester contact and said clip means;
  • said resistance means having a fixed resistance value selected to reduce the level of pulses delivered by said circuit means to said lead by a factor substantially numerically equal to the ratio between the open circuit voltage of said circuit means and an estimated acute threshold current.
  • Cardiac pacer apparatus comprising circuit means for delivering electrical pulses of a predetermined level at intervals
  • lead means including an electrode for contact with spective means for connection to the circuit means cardiac tissue of a patient to deliver said pulses as connector portion and the lead means connector stimuli to the ventricles of the heart, said circuit portion.
  • means and said lead means being provided with re- References Cited s ective matin rtions of a connector p g 5 UNITED STATES PATENTS and signal-attenuating means of a fixed resistance value for selective connection between said circuit means 3,193,195 19 5 Chardack 123-419 and said lead means, said resistance value being selected to reduce the level of pulses delivered to said OTHER REFERENCES electrode by a factor corresponding to the normal 10 Hopps et 1 S 1, 36, N 4 October 1954, post-operative increase in the threshold of ventricular 3334549 (only 333 m d upon) response subsequent to implantation of said electrode, said signal-attenuating means including also re- WILLIAM E.
  • the pacer output oircuit may be designed to deliver.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • Prostheses (AREA)
US685062A 1967-11-22 1967-11-22 Method and apparatus for positioning the ventricular lead of a cardiac pacer Expired - Lifetime US3508538A (en)

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US68506267A 1967-11-22 1967-11-22

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CH (1) CH502108A (fr)
GB (1) GB1239280A (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3625201A (en) * 1969-11-28 1971-12-07 Cordis Corp Tester for standby cardiac pacing
US4640285A (en) * 1985-01-22 1987-02-03 Cordis Corporation Sense margin evaluation system and method for use same
US4830005A (en) * 1987-07-23 1989-05-16 Siemens-Pacesetter, Inc. Disposable in-package load test element for pacemakers
US5237991A (en) * 1991-11-19 1993-08-24 Cyberonics, Inc. Implantable medical device with dummy load for pre-implant testing in sterile package and facilitating electrical lead connection
US5275620A (en) * 1990-05-21 1994-01-04 Telectronics, N.V. Implantable lead connectors and remote lead assembly
US5314452A (en) * 1991-09-23 1994-05-24 Siemens Aktiengesellschaft Protective arrangement for an implantable defibrillator
US20120239113A1 (en) * 2011-03-15 2012-09-20 Jan Vermeiren Mechanical stimulator having a quick-connector
US9469437B2 (en) 2013-01-18 2016-10-18 Cyberonics, Inc. Radiofrequency shielded container

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3198195A (en) * 1962-10-18 1965-08-03 William M Chardack Implantable controls for cardiac pacemakers

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3198195A (en) * 1962-10-18 1965-08-03 William M Chardack Implantable controls for cardiac pacemakers

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3625201A (en) * 1969-11-28 1971-12-07 Cordis Corp Tester for standby cardiac pacing
US4640285A (en) * 1985-01-22 1987-02-03 Cordis Corporation Sense margin evaluation system and method for use same
US4830005A (en) * 1987-07-23 1989-05-16 Siemens-Pacesetter, Inc. Disposable in-package load test element for pacemakers
US5275620A (en) * 1990-05-21 1994-01-04 Telectronics, N.V. Implantable lead connectors and remote lead assembly
US5314452A (en) * 1991-09-23 1994-05-24 Siemens Aktiengesellschaft Protective arrangement for an implantable defibrillator
US5237991A (en) * 1991-11-19 1993-08-24 Cyberonics, Inc. Implantable medical device with dummy load for pre-implant testing in sterile package and facilitating electrical lead connection
US20120239113A1 (en) * 2011-03-15 2012-09-20 Jan Vermeiren Mechanical stimulator having a quick-connector
US8790237B2 (en) * 2011-03-15 2014-07-29 Cochlear Limited Mechanical stimulator having a quick-connector
US9469437B2 (en) 2013-01-18 2016-10-18 Cyberonics, Inc. Radiofrequency shielded container

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GB1239280A (fr) 1971-07-14
CH502108A (fr) 1971-01-31

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